Regulatorische Updates

The FDA granted approval for ANDA 076886, a fosphenytoin sodium injection by DR REDDYS, now listed as discontinued. Original approval in 2007 with labeling updates in 2020.

The FDA approved application ANDA076605 for Ranbaxy’s oral gabapentin tablets (600 mg and 800 mg). Both products are currently listed as discontinued.

FDA approved Sun Pharm Industries Ltd's ANDA 076332 for Fluconazole oral suspension (200 mg/5 mL and 50 mg/5 mL). Both products are now discontinued.

The FDA has issued labeling approvals for ANDA078380, a 20 mg sildenafil citrate tablet by Teva Pharmaceuticals, now listed as discontinued.

FDA approved a labeling supplement for Sun Pharm's amlodipine besylate tablets (2.5 mg, 5 mg, 10 mg) under ANDA078081; the products are currently listed as discontinued.

The US FDA has expanded the indication of Bayer’s oral TKI Hyrnuo, granting accelerated approval as first‑line therapy for HER2‑mutated locally advanced or metastatic non‑squamous NSCLC, based on a 75% ORR in the SOHO‑01 trial.

Alvogen’s discontinued topical gel CICLOPIROX (0.77%) received FDA labeling submissions in 2013, with earlier filings dating back to 1997.

FDA granted approval for PHOTOFRIN, a porfimer sodium injectable marketed by Pinnacle Biologics, under application NDA020451.

FDA has approved ANDA213409 for two oral solution products of nimodipine from ALKEM Labs, with one product receiving prescription status and the other tentative approval.

The FDA has approved ANDA217961 for CARBIDOPA 25 mg oral tablets, a prescription product submitted by Regcon Holdings.

The FDA granted approval (AP) for Bionpharma Inc.’s nicardipine hydrochloride oral capsules, 20 mg and 30 mg strengths, under application ANDA217555.

FDA granted approval for NDA 211281, covering Braintree Labs' PIZENSY oral lactitol solution, with original approval in Feb 2020 and a labeling supplement in Aug 2021.